Orchestra BioMed (OBIO) FDA Approvals

Orchestra BioMed's Drugs in the FDA Approval Process

This section highlights FDA-related milestones and regulatory updates for drugs developed by Orchestra BioMed (OBIO). Over the past two years, Orchestra BioMed has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as Atrioventricular and BACKBEAT. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend. Select a button below to view the list of FDA events for that drug.

Atrioventricular Interval Modulation ("AVIM") Therapy FDA Regulatory Events

Atrioventricular Interval Modulation ("AVIM") Therapy is a drug developed by Orchestra BioMed for the following indication: in the management of hypertensive heart disease. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Provided Update - May 12,2026

• Drug: Atrioventricular Interval Modulation ("AVIM") Therapy
• Announced Date: May 12, 2026
• Indication: in the management of hypertensive heart disease

Announcement

Orchestra BioMed Holdings, announced an update to the overall clinical and regulatory timeline for the BACKBEAT Trial evaluating Atrioventricular Interval Modulation Therapy ("AVIM Therapy") in pacemaker-indicated patients with uncontrolled hypertension despite medications.

AI Summary

Orchestra BioMed Holdings announced an update to the overall clinical and regulatory timeline for its BACKBEAT Trial, which is testing Atrioventricular Interval Modulation Therapy, or AVIM Therapy, in pacemaker-indicated patients who still have uncontrolled high blood pressure despite taking medicine. The company said the therapy is designed to use a pacemaker-based approach to help lower blood pressure in this hard-to-treat group. Orchestra BioMed also noted upcoming presentations about AVIM Therapy at major heart rhythm and heart failure meetings in 2026, showing continued interest in the treatment from the medical community.

The update suggests the company is moving forward with both clinical testing and regulatory planning as it works toward possible broader use of AVIM Therapy. Orchestra BioMed said the treatment is aimed at patients who already need a pacemaker and may offer a new option beyond drugs alone. The company also reminded investors that its plans depend on future results and other risks.

Data Presentation - October 9,2025

• Drug: Atrioventricular Interval Modulation ("AVIM") Therapy
• Announced Date: October 9, 2025
• Target Action Date: October 10, 2025
• Indication: in the management of hypertensive heart disease

Announcement

Orchestra BioMed Holdings, announced a data summary supporting the transformative potential of Atrioventricular Interval Modulation ("AVIM") Therapy in the management of hypertensive heart disease will be presented in a keynote talk at the Georgia Innovation Summit in Tbilisi, Georgia on October 10, 2025.

AI Summary

Orchestra BioMed Holdings announced that a data summary on Atrioventricular Interval Modulation (AVIM) Therapy will be presented in a keynote talk by Avi Fischer, MD, at the Georgia Innovation Summit in Tbilisi, Georgia, on October 10, 2025. The presentation will highlight AVIM Therapy’s potential to halt the progression of hypertensive heart disease through a novel, device-based approach.

AVIM Therapy uses standard dual-chamber pacemakers to adjust the timing between heart chambers, directly lowering blood pressure and improving cardiac function. Early clinical results demonstrate immediate and sustained reductions in 24-hour ambulatory systolic blood pressure—up to 15.6 mmHg on day 1 and 11.1 mmHg at six months—as well as a 17.5 mmHg drop in office systolic pressure at 24 months.

Additional findings include significant improvements in heart rate, end-diastolic volume, and echocardiographic measures of diastolic function without compromising safety. Long-term follow-up confirms durable blood pressure control and reversibility after therapy interruption.

Through its partnership with Medtronic, Orchestra BioMed aims to bring AVIM Therapy to over 750,000 pacemaker-eligible patients worldwide who have uncontrolled hypertension, potentially reshaping the standard of care.

BACKBEAT FDA Regulatory Events

BACKBEAT is a drug developed by Orchestra BioMed for the following indication: AVIM therapy in pacemaker-indicated patients with uncontrolled hypertension despite the use of antihypertensive medications. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

FDA approved - August 8,2025

• Drug: BACKBEAT
• Announced Date: August 8, 2025
• Indication: AVIM therapy in pacemaker-indicated patients with uncontrolled hypertension despite the use of antihypertensive medications.

Announcement

Orchestra BioMed Holdings, announced the roll out of a protocol update, approved by the U.S. Food and Drug Administration ("FDA"), that significantly expands patient eligibility criteria for enrollment of the BACKBEAT study evaluating AVIM therapy in pacemaker-indicated patients with uncontrolled hypertension despite the use of antihypertensive medications.

AI Summary

Orchestra BioMed Holdings announced a protocol update, approved by the U.S. FDA, that expands patient eligibility for the global BACKBEAT study. This trial evaluates AVIM therapy, a new treatment to lower blood pressure in patients with a dual-chamber pacemaker and uncontrolled hypertension despite medication.

The updated criteria now include any hypertensive patient with a Medtronic Azure or Astra dual-chamber pacemaker—first implant or replacement—with sufficient battery life. It also adds patients with mild to moderate heart failure (NYHA class I or II).

Orchestra BioMed estimates these changes increase the potential patient pool by more than 24-fold compared to the original protocol. Rollout began in the third quarter of 2025, with full implementation in the fourth quarter, aiming to complete enrollment by mid-2026.

This update better aligns the study group with older, higher-risk patients who need both a pacemaker and better blood pressure control.